WorksheetsQuality Control of Biotechnologically Produced Drugs
Total questions: 25
Worksheet time: 13mins
Which analytical technique is most commonly used to confirm the molecular weight and identity of recombinant proteins?
UV-Visible spectroscopy
Infrared spectroscopy
Mass spectrometry
Atomic absorption spectroscopy
Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) is primarily used to assess
Protein tertiary and structure
Protein purity and molecular size
Enzymatic activity
Glycosylation pattern
Which technique is most suitable for detecting protein aggregation in biopharmaceutical products?
Size-exclusion chromatography (SEC)
Thin-layer chromatography (TLC)
Gas chromatography (GC)
Paper electrophoresis
The biological potency of biotechnologically produced drugs is usually determined by
Chemical assay
In vitro or in vivo bioassay
UV absorbance measurement
Refractive index analysis
Which method is widely used for host cell protein (HCP) impurity analysis?
ELISA
UV spectrophotometry
Flame photometry
Capillary GC
Detection and quantification of host cell DNA contamination in biopharmaceuticals is commonly performed using
Southern blotting
PCR-based methods
Gel filtration chromatography
HPLC with UV detector
Which analytical technique is best suited to analyze glycosylation patterns of recombinant proteins?
NMR spectroscopy
X-ray diffraction
Polarimetry
Mass spectrometry
Isoelectric focusing (IEF) is mainly used to determine the
Molecular mass of proteins
Amino acid sequence
Isoelectric point (pI)
Secondary structure
Which test ensures that a biotechnological product is free from microbial contamination?
Endotoxin test
Sterility test
Pyrogen test
Preservative efficacy test
The Limulus Amebocyte Lysate (LAL) test is used for the detection of
Viral contamination
Protein degradation
Bacterial endotoxins
Host cell proteins
Which chromatography technique is the most suitable for charge variant analysis of monoclonal antibodies?
Reverse-phase HPLC
Affinity chromatography
Size-exclusion chromatography
Ion-exchange chromatography
Circular dichroism (CD) spectroscopy is mainly used to study
Protein secondary structure
Protein concentration
Protein primary structure
Protein molecular weight
Which method is used to assess the immunogenicity risk of biopharmaceutical products?
Bioassays
ELISA for anti-drug antibodies
UV spectrophotometry
HPLC analysis
Western blotting is particularly useful for
Quantitative protein assay
Protein sequence determination
Specific protein identification
Protein crystallization
Which parameter is most critical when performing stability studies of biotechnologically produced drugs?
Colour
Odour
Packaging material
Biological activity
Biotechnologically produced drugs are best defined as
Drugs synthesized solely by chemical reactions
Drugs obtained from plant extraction only
Drugs produced using living organisms or recombinant DNA technology
Drugs prepared by fermentation without purification
Which of the following is an example of a biotechnologically produced drug?
Recombinant human insulin
Paracetamol
Aspirin
Diazepam
The primary objective of quality control for biotechnologically produced drugs is to ensure
Low production cost
Consistent safety, quality, and efficacy
Rapid market approval
Attractive packaging
Host cell proteins (HCPs) are monitored in quality control because they may
Improve drug stability
Act as preservatives
Increase bioavailability
Cause immunogenic reactions
Biological potency testing is essential because biotechnologically produced drugs
Act mainly through chemical reactions
Rely on biological mechanisms of action
Are unaffected by structural changes
Do not degrade during storage
Why are stability studies especially critical for biopharmaceutical products?
They are always supplied as tablets
They are chemically inert
They are sensitive to temperature and physical stress
They do not require expiry dating
Which organization publishes international guidelines for the quality, safety, and efficacy of biopharmaceuticals?
ISO
ICH
ASTM
FAO
Good Manufacturing Practice (GMP) requirements for biotechnological products emphasize
Final product testing only
Packaging design
Process control and validation
Marketing authorization
Pharmacopeial monographs for biotechnological products primarily provide
Standardized test methods and specifications
Marketing strategies
Clinical trial protocols
Pricing guidelines
The purpose of post-marketing surveillance for biotechnologically produced drugs is to
Increase production yield
Monitor long-term safety and efficacy
Reduce regulatory inspections
Eliminate quality control testing
